Marginal Bone Changes Around Dental Implant Placed with Open Vs. Closed Sinus Elevation

February 2, 2025 updated by: Hebatallah Abdo's Elsaid Mattar, Misr International University

A 36 - Month Randomized Controlled Trial Comparing the Marginal Bone Changes Surrounding Dental Implants Placed with Open Versus Closed Sinus Elevation and Allogenic Bone Grafting.

Background: In cases with atrophic posterior maxilla, sinus elevation techniques are essential for a successful implant placement. The optimal strategy for treating pneumatized maxillary sinus in terms of dental implant insertion and surrounding bone stability has been a scientific conundrum for many years. The objective of this study was to evaluate and contrast the long-term marginal bone alterations around dental implants that were positioned utilizing transcrestal (closed) versus lateral (open) sinus elevation procedures.

Material and methods:

Fifty six dental implants were inserted for patients with inadequate residual bone height due to maxillary sinus pneumatization after receiving approval from Suez Canal University's ethics council. Depending on the method, these patients were randomly assigned to one of two groups: the test group, which received the closed sinus elevation, or the control group, which received the open sinus elevation.Allogenic bone grafting was used to treat the elevated sinuses in both groups.The mesial and distal marginal bone loss for these dental implants was evaluated over a 12-month period following surgery using a standardized digital periapical radiography and the Cliniview Software to measure radiographic bone alterations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Ismailia
      • Ismalia, Ismailia, Egypt, 41522
        • Suez Canal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
  • Adults above the age of 18.
  • Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
  • Good oral hygiene.
  • Patient accepts to sign an informed consent.

Exclusion Criteria:

  • Smokers (more than 10 cigarettes per day).
  • Medically compromised patients.
  • Patients with active infection related at the site of implant/bone graft placement.
  • Patients with untreated active periodontal diseases.
  • Patients with parafunctional habits.
  • Acute or chronic sinusitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lateral Sinus Elevation
Procedure: Open Sinus Elevation
Open Sinus Elevation
Active Comparator: Transcrestal Sinus Elevation
Procedure: Closed Sinus Elevation
Closed Sinus Elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mesial and Distal marginal bone loss
Time Frame: 3 years
Utilizing A standardized digital periapical radiography, and the Cliniview Software to measure radiographic bone changes mesially and distally to 56 implants placed after sinus elevation in the posterior maxilla.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr International University

Collaborators

Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

January 19, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021/419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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